- The Washington Times - Monday, January 21, 2002

The powerful Food and Drug Administration (FDA), which regulates products accounting for 25 cents of every consumer dollar, has been without a head since the end of the Clinton administration. Finding a candidate might have been straightforward, since the agency is in desperate need of reorganization and reform, the Bush White House is generally in favor of regulatory moderation and modernization, and its budget chief, Mitch Daniels, is a savvy former drug company executive who understands the pivotal role of the FDA.

The major stumbling block to an appointment has been the intractability of Democratic senators on the Health, Education, Labor and Pensions Committee, which must confirm senior political appointees at the agency. Its chairman, Sen. Edward M. Kennedy, has vetoed several superb short-listed candidates, making it known that the committee will not consider anyone with strong industry ties.

The compromise candidate is reportedly Dr. Alastair J. J. Wood, vice chancellor and professor of medicine and pharmacology at Vanderbilt University in Nashville. Dr. Wood, a physician who has served on an FDA extramural advisory committee, boasts an impressive resume and seems to be a "mainstream" choice.

What FDA needs now, however, is someone who is not mainstream but extraordinary, someone intimately familiar not only with medicine, but also with the arcana of "regulatory science" and the policy and budgetary issues (such as user fees paid by industry) that are unique to FDA. Most important, the agency needs a superlative manager and avid reformer who will put the timely delivery of life-saving new products ahead of other considerations.

The two Clinton-era FDA commissioners, David Kessler and Jane Henney, presided over an agency that imposed an increasingly intolerable burden on the developers of new drugs. The agency continually introduced new requirements and policies, regardless of their potential to hinder the delivery of new and innovative therapies to patients who need them. Examples include the FDA's disastrous war on silicone breast implants, which wrecked an industry, left women concerned and confused, and interfered with the availability of silicone for other critical uses; new, hugely expensive requirements for reporting drugs' side effects during clinical testing, with minimal benefit to patients; a new requirement for drug trials in children, which may be dangerous and could further delay drug approvals; and unwarranted, debilitating constraints on human gene therapy. (To say nothing of unscientific, debilitating new regulatory requirements for biotechnology-derived foods.)

The FDA has made our drug development system the most cumbersome and expensive in the world. While FDA and its boosters tout modest improvements in the agency's review time for marketing approvals since the mid-1990s, the total time required for drug development, from synthesis of the molecule to marketing approval, has more than doubled (from 6.5 to 14.8 years) since 1964. Bringing a new drug to market now costs upwards of $800 million, by far the highest price tag in the world.

The nominee for FDA commissioner must have several attributes, among them superior management skills and experience. The agency's scope is so sweeping encompassing cardiac pacemakers, X-ray machines, condoms, home pregnancy-testing kits, drugs, vaccines and artificial sweeteners that a single person cannot be expected to master the body of science, medicine and engineering (to say nothing of the legal and regulatory minutia) involved. One must assume that the FDA's own professional staff can frame the issues and options; and the function of the agency head should be primarily to manage the far-flung empire, craft appropriate incentives for moving products through the pipeline, and make the final decision on difficult policy questions.

It is not reassuring that Dr. Wood's primary writings on drug development have focused not on innovative ways to get new products approved, but on drugs' side-effects and mechanisms for withdrawing products from the market. Although the FDA has raised the bar for drug approval in recent years with greater numbers of clinical trials and patients required to support applications for marketing approval Dr. Wood seems unconvinced that drugs approved by the agency's ultra-cautious regulators are, indeed, safe. If he were appointed commissioner, FDA reviewers would likely become even more risk averse, further delaying drug approvals. Moreover, Dr. Wood lacks experience in managing a large enterprise.

The nominee must also possess unassailable integrity and honesty. The incumbent needs to garner the respect of those who have a stake in FDA's policies and decisions patient groups, individual consumers and drug companies with candor and consistency. Dr. Wood's strong biases against industry, which are evident in his writings and pronouncements on drug development, would make this difficult.

There must also be a commitment to regulatory reform. The FDA needs to create incentives for its staff to make patients' needs paramount, make senior and mid-level managers more accountable for their decisions, reduce the current preoccupation with meeting irrelevant bean-counters' milestones, and work with Congress on nongovernmental alternatives to some of the agency's functions. Regulatory reform that corrects the agency's tendency to delay and to become ever more intrusive in Americans' lives will be the new incumbent's greatest long-term challenge but Dr. Wood's record shows that he is likely to reform in the wrong direction.

The FDA, which regulates more than $1 trillion worth of products annually, is omnipresent in Americans' lives. For too long the agency has put public relations before public health, trying to look good instead of doing good. Americans need an FDA commissioner who has superb management skills, appropriate experience and integrity, and who is committed to reforming the agency. It's doubtful that Dr. Wood is the right prescription for what ails the FDA.

Henry Miller is a fellow at the Hoover Institution and the author of "To America's Health: A Proposal to Reform the FDA."

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